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Completed

NCT Number: NCT02983682

Lidocaine Infusions for Chronic Pain in Children

This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic pain in children. All participants will receive lidocaine infusion and severity of pain and degree of chronic-pain related disability will be assessed before and up to 4 weeks after infusion. Adverse events will be recorded.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

Reports have shown that intravenous lidocaine infusions have been effective in relieving chronic pain that has been resistant to other therapies, with minimal side effects. The investigators would like to determine whether severity of pain and degree of chronic-pain related disability could be reduced with lidocaine infusion in children and to understand whether the dose of lidocaine correlates with blood levels in the same manner as it does in adults. The investigators will recruit 24 patients aged 8-18 with chronic pain that has not been relieved by standard therapies. Each patient will receive a lidocaine infusion over 2 hours. Blood will be drawn for lidocaine concentration before the beginning of the infusion, immediately after and 0.5, 2 and 4 hours after. Severity of pain and degree of disability will be recorded using a questionnaire measuring pain scores, sleep disruption, social disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks and then 4 weeks after. This study will help the investigators better understand the effectiveness and safety of intravenous lidocaine for chronic pain in children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with a chronic pain condition (> 3 months) other conventional medical therapies (anticonvulsants, tricyclics etc), have not been effective.
  • American Society of Anesthesiologists class 1 or 2
  • Age 8-18 years
  • Ability to understand and use the numeric rating scale to rate their pain and to understand and answer other questionnaires
  • Negative pregnancy test in participants of child-bearing potential (Females 12 years of age and older, or menarchal if under 12)

Exclusion criteria

  • History of seizures
  • Known liver or renal disease
  • Patient taking strong CYP1A2 inducers or inhibitors (fluvoxamine, phenytoin, cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol)
  • Allergy or sensitivity to lidocaine or other local anesthetic
  • Cardiac conduction anomalies (eg. Heart block, Wolff-Parkinson-White)
  • Serum electrolytes (potassium, sodium, magnesium or calcium) outside of reference ranges
  • Pregnancy

Withdrawal Criteria

  • Patient or parent/guardian request
  • Refusal to have intravenous access and serum levels drawn
  • Inability to complete pain scores on the questionnaires (paper or electronic) at the first infusion and weekly for 2 weeks and at one month following infusion
  • Baseline free carnitine concentration < 26 micromoles/L or total carnitine < 32 micromoles/L (reference values from SickKids Department of Pediatric Laboratory Medicine "Guide to Laboratory Services")

Treatment and study plan

Lidocaine infusion

Drug

Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.

Other names: Preservative Free Lidocaine Hydrochloride

Primary outcomes

  1. Pain Score

    Time frame: Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion

    Pain scores will be measured using the Numeric Rating Scale

Secondary outcomes

  1. Analgesic Requirement

    Time frame: Up to seven days prior to lidocaine infusion.

    Participants will record all analgesics used in a pain diary provided by the investigators.

  2. Analgesic Requirement

    Time frame: Up to one month after lidocaine infusion

    Participants will record all analgesics used in a pain diary provided by the investigators.

  3. Adverse Events

    Time frame: intraoperative

    Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache

Other outcomes

  1. Sleep

    Time frame: Day of the infusion, one week, two weeks and four weeks following the infusion.

    The Adolescent Sleep Wake Scale will be used to assess quantity and quality of sleep.

  2. Pain Interference

    Time frame: Day of the infusion, one week, two weeks and four weeks following infusion.

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale will be used to measure how pain interferes with the participants activities of daily living

  3. School Attendance

    Time frame: Week prior to the infusion and at two and four weeks following the infusion.

    Participants will record the number of hours of school attendance where relevant (e.g. no school holidays, no medical appointments).

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

A Pilot Study of the Effectiveness of Lidocaine Infusions for the Management of Chronic Pain in Children

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2016
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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